On April 14, 2016, the U.S. Food and Drug Administration (“FDA”) issued draft guidance titled “Data Integrity and Compliance with CGMP Guidance for Industry” (the “Draft Guidance”). Noting that the FDA has increasingly observed current good manufacturing practice (“CGMP”) violations involving data integrity, the Draft Guidance seeks to clarify the role of data integrity in CGMP for drugs.
In the Draft Guidance, “data integrity” refers to the completeness, consistency, and accuracy of data. Specifically, the Draft Guidance focuses on data integrity in CGMP as required in 21 C.F.R. parts 210, 211, and 212, which cover CGMP in Manufacturing, Processing, Packing, or Holding of Drugs, CGMP for Finished Pharmaceuticals, and CGMP for Positron Emission Tomography Drugs, respectively.
In the Draft Guidance, the FDA explains that it expects data to be reliable and accurate, as data integrity is an “important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health.” Examples from 21 C.F.R. parts 210, 211, and 212 that are cited by the FDA require: (1) that backup data are exact, complete, and secure from alteration, inadvertent erasures, or loss, (2) that data be stored to prevent deterioration or loss, (3) that certain activities be documented at the time of performance and that laboratory controls be scientifically sound, (4) that records be retained as original records, true copies, or other accurate reproductions of the original records, and (5) complete information, complete data derived from all tests, complete record of all data, and complete records of all tests performed. The Draft Guidance includes recommendations relating to these requirements, covering specific topics such as computer systems access controls, the use of electronic copies of paper or electronic records, retention of static and dynamic records, and the need for training personnel to detect data integrity issues.
The Draft Guidance was published to the Federal Register on April 15, 2016, and comments should be submitted within 60 days thereafter, by June 14, 2016.
Reporter, Stephen R. Shin, New York, +1 212 556 2198, sshin@kslaw.com.
